Medsafe told the Nosoviches to follow this process but they said it was not appropriate for a novel medical device like OncoRob.<\/p>\n
Sophie Nosovich claimed their study showing efficacy in terminally ill cancer patients was a more powerful result<\/a> than any randomised clinical trials.<\/p>\n Medical devices do not need pre-market assessment and approval. <\/p>\n But Armand Nosovich claimed they required a manufacturing certificate which could cost up to $200,000 a year, putting it out of reach for the small facility<\/a>.<\/p>\n Discussions with Medsafe have stopped over fears they could expose Armand Nosovich\u2019s trade secrets \u2013 which he felt was the only way to protect his three decades of research<\/a>.<\/p>\n \u201cNo one in the world has anything close to this. I would like to keep this intellectual property \u2013 it\u2019s my own invention.\u201d<\/p>\n Medsafe said it cannot determine the regulatory pathway without detailed information about the product.<\/p>\n When Medsafe asked for more information about OncoRob\u2019s mode of action<\/a>, the Nosoviches asked the regulator to sign a confidentiality agreement, but this was declined. <\/p>\n They were advised information provided to Medsafe would be available to others through the Official Information Act, putting the trade secrets at risk<\/a>, Sophie Nosovich said.<\/p>\n Novother Cancer Research was effectively in limbo, she said.<\/p>\n \u201cIt\u2019s very slow progressing but in the meantime people are dying [of cancer]<\/a> and don\u2019t have this option.\u201d<\/p>\n Armand Nosovich said he was able to show the benefits<\/a> of OncoRob firsthand, having used it to treat his prostate cancer, diagnosed in 2017.<\/p>\n The Nosoviches have also started a charitable trust called Bio-Robots Against Cancer, which would help fund treatment for patients<\/a> who couldn\u2019t afford it.<\/p>\n Medsafe awaiting information, regulator says<\/p>\n Medsafe said it had sufficient flexibility to regulate novel therapeutic treatments under the Medicines Act 1981, whether they were medicines or medical devices.<\/p>\nNovother Cancer Research’s Sophie Nosovich (from left) and Dr Armand Nosovich hope to offer a world-leading new cancer treatment from their Whang\u0101rei facility. Photo \/ Denise Piper<\/p>\n
Neighbours of Novother Cancer Research were sent this flyer, encouraging them to support its cancer clinic. Photo \/ Denise Piper<\/p>\n
Dr Armand Nosovich (right), supported by his wife, oncology nurse Sophie Nosovich, says OncoRob effectively treated his prostate cancer. Photo \/ Denise Piper<\/p>\n